Ibuprofen is a phenylpropionate or 2-arylpropionic acid also known as 2-[4-(2-methylpropyl)phenyl]propanoic acid.
U.S. Pat. No. 4,279,926 (Bruzzese et al.) discloses pharmaceutical compositions containing salts of phenylalkanoic acids, including the D,L and L lysine salts of ibuprofen and is directed to methods of treating inflammation and pain using the same.
U.S. Pat. No. 5,895,789 (Gentile et al) is directed to pharmaceutical compositions suitable for parenteral administration that contain an alkylammonium salt of a 2-arylpropionic acid, include an aqueous solution having an osmolarity between 270 and 310 mOsm/kg and a pH in the range of 7.0 to 7.5, are free of preservatives and of supporting substances and prepared and kept in an inert gas atmosphere and away from light, as well as a process for preparing these pharmaceutical compositions.
U.S. Pat. No. 6,342,530 (L. Darko) is directed to pharmaceutical compositions in unit dosage form in a vial or ampoule having storage stability over a period of 2 years and suitable for parenteral administration having anti-inflammatory, anti-pyretic and analgesic properties, which consists of a therapeutically effective amount of the d,l or l-lysine salt of R,S or S-ibuprofen as active ingredient dissolved in sterile water to form a solution in the absence of an inert atmosphere and substantially free of any excipient, organic solvent, buffer, acid, base, salt other than the active ingredient and capable of storage in the absence of an inert atmosphere.
Surprisingly it now has been found that an ibuprofen aluminum salt precipitate can form in these pharmaceutical compositions. The presence of the ibuprofen aluminum salt precipitate may result in the ibuprofen alkylammonium salt pharmaceutical composition being unsuitable for therapeutic use. An alkylammonium salt ibuprofen pharmaceutical composition that is substantially-free of an ibuprofen aluminum salt precipitate would be beneficial since the therapeutic use of the pharmaceutical composition would not be compromised. The present invention is directed to these, and other important, ends.